[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652259":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":47,"locations":52,"responsibleParty":74,"collaborators":25,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":25,"enrollmentInfo":87,"targetDuration":25,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":55,"whyStopped":25,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"AHEPA University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BIS 45-55","ACTIVE_COMPARATOR","Participants assigned to this arm will receive total intravenous anesthesia with propofol and remifentanil, adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 45-55, representing standard anesthesia depth.",[13],"Other: BIS-guided anesthesia: BIS 45-55",{"label":15,"type":16,"description":17,"interventionNames":18},"BIS 30-35","EXPERIMENTAL","Participants assigned to this arm will receive total intravenous anesthesia with propofol and remifentanil, adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 30-35, representing deeper anesthesia.",[19],"Other: BIS-guided anesthesia: BIS 30-35",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIS-guided anesthesia: BIS 45-55","Total intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 45-55, representing standard anesthesia depth.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"BIS-guided anesthesia: BIS 30-35","Total intravenous anesthesia with propofol and remifentanil will be adjusted by the treating anesthesiologist to maintain a Bispectral Index (BIS) target range of 30-35, representing deeper anesthesia.",[15],[31,35,39,42,44],{"name":32,"affiliation":33,"role":34},"Vasileios Kamperidis, Assistant Professor","1st Department of Cardiology, School of Medicine, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece","STUDY_CHAIR",{"name":36,"affiliation":37,"role":38},"Despoina Sarridou, Associate Professor","Department of Anesthesiology, AHEPA University Hospital, Aristotle University of Thessaloniki","STUDY_DIRECTOR",{"name":40,"affiliation":41,"role":38},"Helena Argiriadou, Professor","Department of Anesthesiology and Intensive Care, AHEPA University Hospital, Aristotle University of Thessaloniki",{"name":43,"affiliation":33,"role":38},"Antonios Ziakas, Professor",{"name":45,"affiliation":33,"role":46},"Christos Mantzios, Cardiology Resident, MD, MSc","PRINCIPAL_INVESTIGATOR",[48],{"name":45,"role":49,"phone":50,"phoneExt":25,"email":51},"CONTACT","+306983282188","chrismantzios1994@gmail.com",[53],{"facility":54,"status":55,"city":56,"state":25,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"AHEPA University General Hospital of Thessaloniki","RECRUITING","Thessaloniki","54636","Greece","GR",{"type":61,"coordinates":62},"Point",[63,64],22.93493,40.64072,{"lat":64,"lon":63},[67,68,69,70,73],{"name":45,"role":49,"phone":50,"phoneExt":25,"email":51},{"name":25,"role":49,"phone":25,"phoneExt":25,"email":51},{"name":45,"role":46,"phone":25,"phoneExt":25,"email":25},{"name":71,"role":72,"phone":25,"phoneExt":25,"email":25},"Vasileos Kamperidis, Assistant Professor","SUB_INVESTIGATOR",{"name":36,"role":72,"phone":25,"phoneExt":25,"email":25},{"type":46,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Christos Mantzios","Cardiology Resident, First Department of Cardiology, AHEPA University General Hospital of Thessaloniki","100652259","assessment-of-cardiac-function-and-anesthesia-depth-in-patients-undergoing-cardiac-surgery-100652259",false,"NCT07770269","Assessment of Cardiac Function and Anesthesia Depth in Patients Undergoing Cardiac Surgery","Multifactorial Assessment of Cardiac Function Through Deformation Imaging, Hemodynamic Parameters, and Anesthesia-related Variables in Patients Undergoing Cardiac Surgery: The SHAPE Study","SHAPE","Inclusion Criteria:\n\n* Adults aged 18 years or older, irrespective of sex.\n* Scheduled to undergo elective cardiac surgery involving cardiopulmonary bypass (on-pump surgery).\n* Anticipated adequate acoustic window for transthoracic echocardiography.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* \\- Emergency or unscheduled cardiac surgery.\n* Cardiac surgery without cardiopulmonary bypass (off-pump surgery).\n* Refusal or inability to provide written informed consent.","ALL","18 Years",{"count":88,"type":89},70,"ESTIMATED","INTERVENTIONAL",[92],"NA","The SHAPE study is a prospective, randomized study evaluating changes in cardiac function in adult patients undergoing cardiac surgery with cardiopulmonary bypass. The study focuses on how cardiac function changes during surgery and whether the depth of anesthesia may influence these changes.\n\nParticipants are randomly assigned to one of two levels of anesthesia depth, guided by the Bispectral Index (BIS). Cardiac function is assessed using transthoracic echocardiography, including myocardial deformation (strain) imaging and myocardial work measurements. Invasive hemodynamic measurements obtained during surgery are also recorded.\n\nThe primary objective is to assess the change in left ventricular global longitudinal strain (LV GLS) between two intraoperative time points: after induction of anesthesia and before cardiopulmonary bypass, and after separation from cardiopulmonary bypass. The study will also examine whether these changes differ according to the assigned depth of anesthesia and whether echocardiographic and hemodynamic measurements are associated with postoperative outcomes.\n\nParticipants will also undergo follow-up echocardiographic assessment at 3, 6, and 12 months after surgery to evaluate longer-term changes in cardiac function.",[95],"Heart Disease",[97,98,99,100,101,102,103,104,105,106],"Cardiac Surgery","Cardiopulmonary Bypass","Global Longitudinal Strain","Myocardial Work","Speckle-Tracking Echocardiography","Bispectral Index","Depth of Anesthesia","Hemodynamic Monitoring","Swan-Ganz Catheter","Low Cardiac Output Syndrome","2026-08-18",{"date":109,"type":110},"2026-08-19","ACTUAL",{"date":112,"type":110},"2026-01-19",{"date":114,"type":89},"2027-11",{"name":5,"class":6},1]